Clinuvel Pharmaceuticals Limited · ASX:CUV
Clinuvel Pharmaceuticals — Jefferies Healthcare Conference 2019
13 slides from Clinuvel Pharmaceuticals's conference presentation, Jun 7, 2019
Slide 1: Scenesse: World's First Systemic Photoprotective
For personal use only SCENESSE® WORLD’S FIRST SYSTEMIC PHOTOPROTECTIVE CLINUVEL PHARMACEUTICALS LTD FROM CONCEPT TO COMMERCIALIZATION JEFFERIES HEALTHCARE CONFERENCE NEW YORK 6 JUNE 2019 Philippe Wolgen ASX: CUV Nasdaq Int’l: CLVLY CEO Xetra-Dax: UR9
Slide 2: Safe Harbour Statement 2019
SAFE HARBOUR STATEMENT 2019 For personal use only This release contains forward-looking statements, which reflect the current beliefs and expectations of CLINUVEL’s management. Statements may involve a number of known and unknown risks that could cause our future results, performance or achievements
Slide 3: SCENESSE (afamelanotide 16mg)
SCENESSE® (afamelanotide 16mg) For personal use only ➢ new molecular entity (NME) = synthetic 13 aminoacid peptide (API) ➢ novel controlled-release subcutaneous injectable implant (polymer) ➢ dose frequency 60 days ➢ first-in-class therapy in erythropoietic protoporphyria (EPP) ➢ world’s first syste
Slide 4: CLINUVEL – translational use melanocortins
CLINUVEL – translational use melanocortins For personal use only S Proof of concept - porphyrias (EPP, CEP) 1991- 2019 EPP [COMPLETED] • pandermal protection, visible light (>408nm) Additional indication A Photo protection, DNA repair F Vitiligo [Ph II] Systemic repigmentation (total body) • 1st pha
Slide 5: CLINUVEL Register
CLINUVEL REGISTER For personal use only IPO 2001 Australian Securities Exchange 48,960,633 ordinary shares ASX-300: CUV [07 SEP 2018] Geographic distribution VWDA 204,808 [0.42% of OSC] JAN 2016 – JUN 2019 35.00 Australia VWDA : 39,238 204,808 30.00 0.09% 0.42% 25.00 Europe 20.00 North America 15.00
Slide 6: Financials
R&D 2005-2016 COMMERCIAL 2016 - cost-management - cost-management FINANCIALS - equity financing - cash positivity - never below critical cash - profitability For personal use only - financial proof of principle 2010 - debt-free - first dividend FY18 $30.00 60 79% 87% EPS A$ cents $20.00 40 A$M $10.0
Slide 7: Product Pipeline
Product Pipeline For personal use only Pre- Programme – SCENESSE® (afamelanotide 16mg) clinical Phase I Phase II Phase III Approved SCENESSE® in adult EPP patients (Europe) SCENESSE® in adult EPP patients (USA) SCENESSE® in adult EPP patients (Australia, Japan) SCENESSE® in adult vitiligo patients (
Slide 8: Erythropoietic protoporphyria (EPP)
Erythropoietic protoporphyria (EPP) For personal use only Phototoxic reaction in an EPP patient. ➢ FECH deficiency 18q21, part of the heme metabolic pathway Image courtesy of the KE family. ➢ Ill-characterized, poorly understood disease ➢ Absolute intolerance to blue/green/UVA/UVB light (i) Phototox
Slide 9: SCENESSE in Erythropoietic Protoporphyria (EPP)
SCENESSE® IN ERYTHROPOIETIC PROTOPORHYRIA (EPP) For personal use only ➢ EMA – MA 2014: standard of care for EPP in European Union, Switzerland • rare genetic metabolic disorder, 1:140,000 • 17 countries with known EPP patients ➢ Commercial roll out, focused specialized team • disciplines across clin
Slide 10: SCENESSE in Vitiligo
SCENESSE® IN VITILIGO For personal use only Clinical Objectives 1. repigmentation face/head/neck 2. follicular response 3. safety profile Ph II CUV102 n=54 [2013] - extent of repigmentation VASI (p<0.025) - time to repigmentation - face (p=0.01) - JAMA Dermatology 2013, 2015 - maintenance of pigment
Slide 11: SCENESSE in Vitiligo
SCENESSE® IN VITILIGO For personal use only Day 0 Day 55 Day 111 Day 176 Baseline After 15 NB-UVB After 27 NB-UVB After 40 NB-UVB treatments, 1 implant treatments, 3 implants treatments, 4 implants
Slide 12: Summary – CLINUVEL Pharmaceuticals
SUMMARY – CLINUVEL PHARMACEUTICALS For personal use only ➢ SCENESSE® innovative medical concept – world’s first systemic photoprotective drug (Rx) ➢ Commercialized orphan medicinal product (NME) in Europe • Erythropoietic protoporphyria (EPP) – rare genetic metabolic disorder • Generating Real World
Slide 13: Gratitude to CLINUVEL Global Teams
For personal use only CLINUVEL PHARMACEUTICALS LTD JEFFERIES HEALTHCARE CONFERENCE NEW YORK 6 JUNE 2019 GRATITUDE TO CLINUVEL GLOBAL TEAMS FOR 14 YEARS OF TENACITY
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